Ethinyl Estradiol and Desogestrel tablet

What is this medicine?

ETHINYL ESTRADIOL;DESOGESTREL is effective as oral contraceptive (birth control pill or "the pill"). It can also help regulate menstrual flow, treat acne or may be used for other hormone related problems in females.

What should my health care professional know before I use this medication?

They need to know if you have or ever had any of these conditions:

blood clots

blood sugar problems, like diabetes

cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional

depression

fibroids

gallbladder disease

heart or circulation problems

high blood pressure

jaundice

liver disease

menstrual problems

migraine headaches

stroke

systemic lupus erythematosus (SLE)

tobacco smoker

an unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives

pregnant or trying to get pregnant

breast-feeding

How should I use this medicine?

Take ethinyl estradiol/desogestrel pills by mouth. Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day and in the order directed. Swallow the pills with a drink of water. Take with food to reduce stomach upset. Do not take more often than directed.

Most of the 28 tablets contain active hormones. This product should be started on the first Sunday after you start your period or on the first day of your period.

Keep an extra month's supply of your pills available to ensure that you will not miss the first day of the next cycle.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

Try not to miss a dose. If you do, it may be necessary to consult your health care professional.

If you miss one dose, take it as soon as you remember and then take the next pill at the regular time as usual. You may take 2 tablets in one day. If you miss two doses (days) in a row, take 2 tablets for the next 2 days, then, continue with your regular schedule. Whenever 1 or 2 doses are missed, you should use a second method of contraception for the next 7 days in addition to taking the pills. If you miss three doses in a row, you should notify your physician or other health care professional for instructions. You will probably need to throw away the rest of the tablets in that cycle pack and start over. Another method of contraception should be used until at least 7 doses have been taken in the new cycle. Missing a pill can cause spotting or light bleeding.

If you miss 1 of the last 7 pills, you can either double the dose or skip it, but it is important to start the next month's cycle on the scheduled day.

You will also need to contact your health care provider for specific instructions based on which tablets have been missed, for how many days they have been missed, and based on what week of your current cycle you are currently taking tablets.

medicines for anxiety or sleeping problems, such as diazepam or temazepam

medicines for mental depression

medicines for diabetes, including troglitazone and pioglitazone

mineral oil

modafinil

mycophenolate

nefazodone

oxcarbazepine

phenytoin

prednisolone

ritonavir or other medicines for the treatment of the HIV virus or AIDS

selegiline

soy isoflavones supplements

St. John's wort

tamoxifen or raloxifene

testolactone

theophylline

topiramate

warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medicines.

What should I watch for while taking this medicine?

Visit your health care provider for regular checks on your progress. You should have a complete check-up every 6 to 12 months. If you have any unusual vaginal bleeding contact your prescriber or health care professional for advice. If you miss a period, the possibility of pregnancy must be considered. See your prescriber or health care provider as soon as you can.

Use an additional method of contraception during the first cycle that you take these tablets.

If you stop taking these tablets and want to get pregnant, a return to normal ovulation can take some time. You may not return to normal ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with your health care provider.

If you are taking oral contraceptives for the treatment of acne, hirsutism (male-like hair growth), endometriosis or other hormone related problems, it may take several months of continued treatment to notice improvement in your symptoms or condition.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking ethinyl estradiol/desogestrel, especially if you are more than 35 years old. You are strongly advised not to smoke.

Oral contraceptives can increase your sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing during long periods outdoors. Tanning booths should be used with caution.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

You may get a vaginal yeast infection. If you have never had a yeast infection before, see your prescriber or other health care provider to confirm the problem. If you have had yeast infections in the past and are comfortable with self-medicating the problem, get and use a nonprescription medication to treat the yeast infection.

If you are going to have elective surgery, you may need to stop taking your contraceptive pills one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

Taking contraceptive pills does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from taking this medicine?

Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking oral contraceptives. On average, more women have problems due to complications from getting pregnant than have problems with oral contraceptives. Many of the minor side effects may go away as your body adjusts to the medicine. However, the potential for severe side effects does exist and you may want to discuss these with your health care provider.

The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help:

chest pain

coughing up blood

dizziness or fainting spells

leg, arm or groin pain

severe or sudden headaches

stomach pain (severe)

sudden shortness of breath

sudden loss of coordination, especially on one side of the body

swelling of the hands, feet or ankles, or rapid weight gain

vision or speech problems

weakness or numbness in the arms or legs, especially on one side of the body

Other serious side effects are rare. Contact your health care provider as soon as you can if the following side effects occur:

breast tissue changes or discharge

changes in vaginal bleeding during your period or between your periods

headaches or migraines

increases in blood sugar, especially if you have diabetes

increases in blood pressure, especially if you are known to have high blood pressure

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